Ensuring compliance

Compliance Solutions has many years of experience within the life science industry advising on how to best meet the regulatory requirements of the MHRA, FDA, Notified Bodies and ICH.

Compliance Solutions understands that businesses will often have varying requirements for consultancy support to meet the fluctuating needs of particular projects and activities, and supports its clients by providing a risk-analysis based approach to meeting their quality and regulatory needs.

We provide our clients with guidance to assist with the development, approval, manufacture, storage and distribution of their products, understanding that your business will often have a varying requirement for consultancy support to meet the fluctuating needs of particular projects and activities.

The company offers end-to-end support from development through quality management systems, regulatory submissions and clinical trials, with services including, but not limited to:

⊲ Clinical Evaluation, including CEP/CER

⊲ Periodic Safety Update Reports (PSUR)-

⊲ Post Market Performance Follow-Up (PMPF)Report

⊲ Summary of Safety and Clinical Performance (SSCP)

⊲ Performance Evaluation Plan and Reports

⊲ Biological Safety Evaluation (ISO 10993) - BER/BEP

⊲ Toxicological Evaluation

⊲ Sterilisation assessment and support

⊲ UKCA & CE Marking

⊲ MDR Support

⊲ IVDR Support

⊲ Technical File Creation/Remediation, including supporting Documentation

⊲ Perform gap analysis of Technical File or Design Dossiers.

Compliance Solutions will be exhibiting on Stand A19 at Med-Tech Innovation Expo.

Nelipak to highlight sustainability commitment

Nelipak will highlight its commitment to sustainability and its advanced simulation capabilities for pharma and medical device packaging at Med-Tech Innovation Expo 2023.

Nelipak is a globally recognised leader in the design and manufacturing of rigid and flexible packaging solutions for demanding applications such as medical device, diagnostic, and pharmaceutical drug delivery. With in-house design, prototyping, tooling, simulation, validation, laboratory, and other value-added services, Nelipak can meet customers’ end-to-end packaging needs. The company also has a range of custom-made sealing machines ideal for Class 7 cleanroom use.

At Med-Tech Innovation Expo, Nelipak will be showcasing its latest services and capabilities for medical device and pharmaceutical packaging at Stand B31. Pharmaceutical packaging is a particularly crucial component of the industry to ensure drug efficacy and regulatory compliance, and Nelipak has extensive experience working with high barrier materials to ensure the safety and efficacy of the active ingredients.

With 1,400 employees and 11 sites globally, Nelipak is trusted by many of the world’s medical device OEMs and pharma companies to deliver superior quality, service, and customer experience. Nelipak has been supplying its industry-leading range of flexible healthcare packaging products to customers worldwide from three production sites located in Europe. Now, its latest purpose-built site in WinstonSalem, North Carolina, expands flexible packaging production capacity in the Americas. Nelipak’s flexible healthcare packaging product line includes rollstock, die-cut lids and sheets, pouches, and bags.

Sustainability is a significant focus for the healthcare industry, and Nelipak is committed to supporting and advancing it in the design and manufacture of healthcare packaging. One way that Nelipak does this is with FEA simulation technology to optimise product design. The NeliSim simulation platform highlights opportunities within existing or new design proposals in the early stages of development. It helps determine the optimal raw material type and gauge, which allows engineers to reduce the amount of material used to strengthen/protect the product. The technology is customised specifically for thermoformed packaging for the medical and pharmaceutical healthcare market. NeliSim uses a combination of techniques to predict material distribution across complex tray designs, identify areas of opportunity such as minimum wall and flange thickness in the physical pack, and indicate likely failure modes determined in transit tests.

Nelipak will be exhibiting at Med-Tech Innovation Expo on Stand B31 or you can visit https://www.nelipak.com/ to learn more about its packaging solutions for the medical and pharmaceutical industries.